By: Jinrong Liu | Shifang Guo | Liang Gao
On 26 February 2016, the China Food and Drug Administration (“CFDA”) introduced the new Administrative Measures on the Registration and Record Filing of Health Food (the “Administrative Measures”) which shall enter into force on 1 July 2016, and the current Administrative Measures on the Registration of Health Food (Pilot Version) (the “Pilot Version”) will henceforth be repealed.
Over the past few years, the health food industry has a growing demand for the introduction of a new administrative mode with respect to health food; as such, the “Food Safety Law” which was amended last year, makes a bit large modifications to the provisions on the administration of health food; in particular, it has introduced the “double-track” health food registration and record filing mechanism, and specifically sets out the categories of health food which are subject to either registration or record filing. Just on that basis, CFDA enacted the “Administrative Measures” so as to reflect the new provisions under the “Food Safety Law” as well as to elaborate thereon; as a consequence, the relevant provisions have become more operable. This article is to introduce and sort out the main provisions of the “Administrative Measures”, and the main amendments thereof vis-à-vis the old Pilot Version.
(1) Administrative mode: the new “Administrative Measures” has introduced a combination of registration and record filing mechanism in terms of the administrative mode of health food, in place of the single registration mode as provided under the old “Pilot Version”. To be specific, CFDA takes charge of the registration of health food as well as of the record filing of health food first-ever imported in relation to nutrient substance such as vitamin supplements, mineral substance, etc. And food and drug agency (FDA) at the provincial level is in charge of the record filing of health food existing within its administrative territory. FDA at the city and county level plays a role inregulating the registration and recordfiling of health food within its administrative territory; in other words, FDA at the city and county level has no power to directly approve the registration or record filing of health food.
(2) Definition of the registration: the new “Administrative Measures” provide that on application by the registration applicant, FDA, in accordance with the legal procedures, conditions and requirements, shall undertake systematic review and appraisal of therelevant application materials in relation to the safety, health function and quality controllability of health food, and decides whether or not to approve the registration.
(3) Definition of the record filing: the new “Administrative Measures” provide that health food production enterprises, as per the legal procedures, conditions and requirements, submit to FDA the materials concerning the safety, health function and quality controllability of products for documentation, publicity and future reference. As set out above, the record filing of health food was newly introduced;compared with the registration procedures, the time limit of the procedure of record filing is relatively short; therefore, for health food manufacturers whose products are subject to record filing procedures, the product market launch periodwould be shortened accordingly.
(4) Registration requirements: under the new “Administrative Measures”, health food with ingredients falling outside the list of health food ingredients and health food first-ever imported (excluding health food in relation to nutrient substance such as vitamin supplements, mineral substance, etc.) are subject to the registration. Moreover, in respect of the procedure of registration, the new “Administrative Measures” set out very specific and strict requirements on the appraisal contents, appraisal procedures, total time limit and the basis of decision. To be specific, the appraisal body is responsible for organizing appraisal experts to carry out the review of application materials, and where necessary for organizing the inspection body to undertake on-site inspection and for organizing the inspection body to go through check inspection. The appraisal should be completed within 60 days, and the appraisal body shall then proceed to submit to CFDA the comprehensive appraisal conclusion and suggestion. In particular, the appraisal body has the power to terminate the appraisal in case that any sectionregarding material review, on-site review, dynamic sampling and check inspection is not in line with the requirements, and accordingly it may propose that the registration cannot be accepted.
In respect of supplementary materials during the procedure of registration, if the appraisal body deems that supplementary materials need to be presented by the registration applicant, the applicant shall be informed of all supplementary contents inanone-off manner. And the applicant shall provide the supplementary materialsin an one-off manner within 3 months as per the requirements of supplementary notice.
(5) Technology transfer: in respect of technology transfer, the new “Administrative Measures” require the transferee to make application for the product registration again under the guidance of the transferor; and technical requirements of products should be in line with the original application materials. And the appraisal body shall simplify the appraisal procedures in accordance with relevant provisions.
(6) Record filing requirements: the new “Administrative Measures” elaborate on the record filing requirements of health food to the benefit of the practice of the applicant; in particular, health food with ingredients falling within the scope of the list of health food ingredients and health food first-ever imported in relation to nutrient substance such as vitamin supplements, mineral substance, etc., under the new “Administrative Measures”, shall go through the procedure of record filing. With respect to health food first-ever imported in relation to nutrient substance such as vitamin supplements, mineral substance, etc., its nutrient substance should be included in the list of health food ingredients.
To be specific, after receipt of the materials of record filing and if the record filing materials meet the requirements, FDA should go through the procedures of record filing on the spot; and if the record filing materials fail to meet the requirements, the record filing applicant should be informed of the supplementary materials inan one-off manner. In respect of health food with record filing, FDA should make the record filing certificate according to relevant requirements and proceed to make public on its websites the information described in the form of record filing information.
The record filing procedures shall be applicable, in case that the ingredients of registered health food have been already contained in the list of health food ingredients and are in line with the relevant technical requirements and when the registrant makes application for change to registration or for continuation of registration upon expiry.
(7) Qualifications of the record filing applicant: the “Administrative Measures” also set out qualifications of the record filing applicant. To be specific, the record filing applicant for domestic health food should be health food production enterprises and the original registrant can also act as the record filing applicant. With respect to imported health food, the record filing applicant should be overseas manufacturers of health food on the market.
(8) Supporting work: in view of the importance of the list of health food ingredients and the list of health function alleged by health food to the registration and record filing of health food, currently CFDA, in collaboration with health administrative department of State Council and national Chinese medicine competent authority, is in the process of enacting relevant administrative measures and supporting lists.
(9) Problem of existing registration application and approved registrations: with respect to the existing registration application, CFDA will apply the new “Administrative Measures” to the appraisal work; in respect ofthe registered health food, CFDA will undertake the work of clearance and renewal of certificate on the basis of the principles of “batch by batch”, legality and steady progress. Through the work of clearance and renewal of certificate, the consistency between the new and old appraisal standards will be ensured.
(10) Naming: the “Administrative Measures” elaborate on the naming details of health food; in particular, it specifically sets out the no-go areas, e.g., words that explicitly or implicitly indicate the function of prevention or therapy.
Health food industry in China has the massive potential and more and more consumers have the demand of health food; for health food manufacturers, huge demand means vast business opportunity. Nevertheless, the issue of market access has a significant effect on the health food manufacturers. The “Administrative Measures” enacted by CFDA makegreat contribution to the manufacturers entering health food market. First of all, such “Administrative Measures” have introduced the mechanism of record filing, thus changing the previous single registration mode; as a result, some health food which were subject to the burdensome registration procedures, now have the chance to make application for record filing; for the manufactures, this change, to a large extent, alleviates their burden of administrative procedures, and it can be expected that the process of some health food entering the market will be accelerated. Second, the “Administrative Measures” set out very specific details on the procedures of registration and record filing; in particular, the time limit of decision-making by FDA has been clearly stipulated therein. Therefore, the operability of procedures of registration and record filing will be increased while the predictability of the implementation of the “Administrative Measures” can also be improved.
We are aware that on 15 February, CFDA made public on its websites the notice concerning public consultations on the list of health good ingredients (the first batch); following the entry into force of the official texts of such list, the scope of application in relation to the registration and record filing mechanism concerning health food would be further defined. (The End)
